The public relies upon a medical value chain system that integrates doctors, dispensers, and manufacturers of medical products and devices in order to provide many types of health-related products and services. Each group in this value chain adds significant expertise and efficiencies to bring to bear the best possible degree of care at reasonable prices for as many people as possible. Moreover, various mechanisms oversee the practices of each of these groups in order to ensure that each participant is providing products or services that meet or exceed acceptable standards that are established by authoritative bodies, such as the Food and Drug Administration. Various licensing and self-governing associations, such as the American Medical Association, oversee the expertise and competency of our doctors and their ability to exercise sound medical judgment. Dispensers of medical products are licensed and monitored by various authorities to ensure that medications and medical devices are dispensed in accordance both with law and the instructions of the prescribing Health Care Professional (HCP). HCP may generally include physicians, Eye Care Practitioners (including optometrists and ophthalmologists), dentists, oral surgeons, veterinarians, neurologists, psychiatrists, psychologists and all others who are licensed, registered or otherwise permitted, by the United States or the jurisdiction in which he or she practices and is empowered to issue prescriptions or medical diagnoses. Manufacturers must first obtain FDA-approval to manufacture and market medicines and medical devices to the general public.
One element that integrates doctors, patients, dispensers and manufacturers is the prescription. Prescriptions are authoritative records that contain a doctor's diagnosis and/or specific instructions for treatment of a particular patient's diagnosed condition at a specific point in time. Prescriptions are therefore personal and timely, in that a prescription that is good for one individual is not necessarily good, and can be harmful, for another individual or even the same individual after the passage of time. Moreover, prescriptions establish a limitation on the specific dosage, frequency of use, refill amounts, expiration date and other usage requirements or limitations, thereby making the prescription correspond with specific time and application parameters specified by the prescribing doctor.
The prescription most often specifies a medication or medical device intended to address the patient's particular condition as diagnosed by the doctor. The prescription of a particular medicine or medical device presumes both that the product is currently formulated and is currently produced by a recognized manufacturer (or can be produced on site). The prescription further presumes reasonable availability through a recognized source for dispensing. Thus the prescription links together the doctor, the patient, the dispenser and the manufacturer in a prescription value chain. “Dispenser” generally refers to one who prepares and distributes medication, medical devices or medical and/or insurance services to patients as specified by a prescription, the basis for which may either be for-profit or not-for-profit. Other terms that may be interchangeably used in the present context would include without limitation “pharmacy”, “retailer”, “vendor”, “merchant”, “point of sale”, “seller” and others.
This integrative prescription system has served us well for many decades. Earlier in our history, patients, physicians and pharmacists resided within relatively small communities; they were likely to have known each other personally and to have been able to recognize each other in person. This general familiarity allowed for a system whereby a physician could issue a prescription document to the pharmacist (who at earlier part of our society prepared the medication on-site) via the patient. This traditional system presumed the prescription to be bona fide and that the person presenting the prescription for fulfillment had been examined by a qualified, licensed physician and found to have a particular medical condition that warranted the medication or treatment specified on the prescription document. Seldom was there a challenge advanced as to the legitimacy of the actual prescription document itself, the authenticity of the underlying diagnosis, or the specific information contained within the prescription. Rather, prescriptions have been generally regarded as bona fide medical instructions from a particular, licensed physician for a particular patient concerning a particular medication or for a particular medical supply or device. Upon presentation of a prescription, fulfillment was customarily straightforward.
However, new forms of care delivery (such as HMOs and diagnoses over remote distances via technology) have emerged and the manner by which doctors, patients, dispensers and manufacturers interact has changed greatly from those earlier days. Where once a patient might have been readily recognized by both the prescribing physician and pharmacist—or at least the prescription document presented was presumed by the pharmacist to be legitimate—now prescriptions pass from an HMO physician to a new patient (whom the physician might see only once) who then seeks to have the prescription filled in a distant city or from an on-line dispenser (sometimes referred to as an internet pharmacy). As a result of these changes, the familiarity between the participants in the prescription cycle has declined to the extent that the participants in the prescription system are most often strangers to one another. Yet despite these professional and market changes, the traditional prescription itself has remained essentially unchanged.
Problems such as prescription misrepresentations, prescription misuse and prescription fraud have arisen. Individuals without a legitimate medical condition have nevertheless presented forged prescriptions to a pharmacist in order to acquire certain desired medications. In other instances, individuals with a legitimate medical condition have sought out multiple qualified, licensed doctors to validate their condition and acquire multiple prescriptions in order to obtain a desired medication in a quantity that exceeds the prescribed refill or volume limits of any single prescription. In still other instances, individuals have sought to self-diagnose their ailments and acquire prescription medications without ever having had an original prescription, as has reportedly occurred in on-line purchases of pharmaceuticals. In still other instances, individuals have stolen the identity of licensed medical practitioners in order to submit fraudulent insurance claims. Moreover, there is concern that many imported pharmaceuticals are acquired without a valid prescription being in place.
The intrinsic authoritative value of a prescription has thus declined in this environment. Once a prescription document itself leaves a doctor's office, the doctor does not have the ability to monitor whether the prescription has been dispensed and at what rate, to cancel or otherwise adjust the prescription, or to monitor any fraudulent use of the prescription itself, such as the duplication or forging of information contained on the prescription paper. Moreover, Health Care Professionals prescribe medicines or medical devices for a patient without having the opportunity or capability to review an empirically verifiable prescription history for that patient, because a patient might be under the care of multiple physicians with various areas of expertise, and because the current prescription system does not create a systemic archival record of all prescriptions per individual patient.
Consumer choice is limited and constrained by this dissonance. With the emergence of digital commerce, consumer options have increased dramatically. Consumers today cannot only buy products from traditional brick-and-mortar stores, but from on-line sources, including the manufacturers themselves. Patient interest in such alternative channels through which to acquire medication, medical devices, and medical and diagnostic services has greatly increased due to convenience, service, and price issues. But because dispensing of prescription products requires that a bona fide prescription be presented or otherwise verified prior to dispensing, order fulfillment can be delayed in order for prescription verification to be made. For example, the Fairness to Contact Lens Consumers Act of 2004 (FCLCA) allows for an eight-hour time frame within which prescribing Eye Care Professionals can respond to verification requests made of them by dispensers. In some instances, incompatibility between on-line fulfillment of prescriptions and laws or regulatory requirements has led to estoppels against on-line medical product transactions. At least one state has required that a prescription document be surrendered to a licensed dispenser prior to prescription fulfillment. However, this requirement effectively prevents on-line pharmacies from operating legally within the state.
Businesses that dispense or supply medicines, medical devices, and medical services (such as diagnostic testing) and insurance services to the public have become increasingly concerned about the authenticity of prescriptions, but these same businesses lack a quick, efficient and cost-effective means to verify the legitimacy of a prescription document that has been presented to them. For example, contact lens dispensers are required by the FCLCA to verify a contact lens prescription with the prescribing doctor. Yet as mentioned above, order fulfillment will be slow with any system that utilizes the full 8-hour window for verification allowed by law.
One recent approach to resolve these problems is the use of specialty papers. Specially-made prescription papers bear various physical properties or characteristics that differentiate the prescription paper from normal paper, and thereby enable a ready determination that a particular prescription is a bona fide document. Holographic images, watermarks, security strips (such as are currently found in most recent editions of US paper currency) and other physical property papers have been introduced to enable immediate recognition of the prescription as bona fide. However, if the paper itself is stolen and fraudulent prescription information forged onto it, then the fraud prevention goal of such specialty paper is defeated.
Thus the absence of a reliable and rapid system to verify the legitimacy of a medical or eye care prescription and prescription refills presented for fulfillment is believed to result in higher costs, operational inefficiencies, fraud (including counterfeit prescriptions and doctor shopping), and in some instances, injury or even death (where fraud has led to purchase and use of pharmaceuticals without a doctor's prescription). There remains a need for a method or system to prevent misuse, misrepresentation and fraud of prescriptions and to enable a method or system by which all legitimate participants in the prescription generation and dispensing cycle can reliably ascertain that a particular prescription and each prescription refill are bona fide. There also remains a need for a method or system to enable patients to manage prescription refills separately and individually, so as to increase consumer choice, flexibility to use multiple suppliers using one prescription and to securely verify prescription information to exclude fraud and doctor shopping.